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Manufacturing Validation Engineer
Eingestellt von Berry Technical
Gesuchte Skills: Engineer, Support
Projektbeschreibung
MANUFACTURING ENGINEER VALIDATION
Solothurn, Switzerland
Contract- until the end of 2013
Our client requires a manufacturing validation engineer to support the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of our clients validation Policies and Procedures are addressed.
Primary Tasks and Responsibilities
*Serves as technical expert for the Validation process and responsibilities to ensure compliance
*Continuous Learning/Managing
*Suggest and sometimes may implement innovation and continuous improvement within the Validation process
* Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
*Facilitates successful team behavior within Quality Systems and across functional areas
*Manages relationships externally and internally.
*Builds cross-functional and cross-departmental support, fostering overall effectiveness Fosters harmony within Quality Systems. Influences and persuades so as to bring about technical and process improvements.
Technical Profile Requirements
*Knowledge of bespoke validation.
*Process knowledge and documentation.
Desirable:
* In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
* High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
*Working experience of validation computer systems for use in a FDA regulated environment.
*Experience in Process Validation, Medical Devices, Mechanical and Chemical Processes, 21 FDA 820
Knowledge & Skills:
Required degree/certificates:
Junior Engineer or Technician
Specific languages:
German - good understanding/English fluent
Solothurn, Switzerland
Contract- until the end of 2013
Our client requires a manufacturing validation engineer to support the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of our clients validation Policies and Procedures are addressed.
Primary Tasks and Responsibilities
*Serves as technical expert for the Validation process and responsibilities to ensure compliance
*Continuous Learning/Managing
*Suggest and sometimes may implement innovation and continuous improvement within the Validation process
* Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
*Facilitates successful team behavior within Quality Systems and across functional areas
*Manages relationships externally and internally.
*Builds cross-functional and cross-departmental support, fostering overall effectiveness Fosters harmony within Quality Systems. Influences and persuades so as to bring about technical and process improvements.
Technical Profile Requirements
*Knowledge of bespoke validation.
*Process knowledge and documentation.
Desirable:
* In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
* High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
*Working experience of validation computer systems for use in a FDA regulated environment.
*Experience in Process Validation, Medical Devices, Mechanical and Chemical Processes, 21 FDA 820
Knowledge & Skills:
Required degree/certificates:
Junior Engineer or Technician
Specific languages:
German - good understanding/English fluent
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Sonstiges